FDA product code NHC: Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
NHC is the FDA product code for catheter, ventricular (containing antibiotic or antimicrobial agents). It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under NHC, from 2 different applicants. The average 510(k) review took 82 days (median 70). FDA has posted 2 recalls for NHC devices.
Definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) |
| Device class | Class II |
| Regulation | 21 CFR 882.4100 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NHC clearance
Top NHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook, Inc. | 2 | 2007-07-12 |
| Cook Incorporated | 1 | 2016-04-08 |
Most recent NHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160223 | Cook Incorporated | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | 2016-04-08 | 70 |
| K071640 | Cook, Inc. | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | 2007-07-12 | 27 |
| K011812 | Cook, Inc. | SPECTRUM VENTRICULAR CATHETER | 2001-11-08 | 150 |
Recalls for NHC devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-31.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NHC?
NHC is the FDA product code for catheter, ventricular (containing antibiotic or antimicrobial agents). It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel.
What device class is NHC?
Class II, regulation 21 CFR 882.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHC?
Across 3 cleared submissions the average was 82 days from receipt to decision (median 70).
Which companies have the most NHC clearances?
Cook, Inc. (2); Cook Incorporated (1).
Have NHC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code NHC
- Run a recall and safety report across every NHC manufacturer
- Watch product code NHC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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